IFUSE IMPLANT SYSTEM

K131405 · SI-BONE, Inc. · OUR · Oct 16, 2013 · Orthopedic

Device Facts

• Record ID: K131405
• Device Name: IFUSE IMPLANT SYSTEM
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Oct 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iFuse System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

iFuse Implant System consists of porous plasma spray coated titanium implants; lengths 30-90mm; diameter 4-7mm. Used for surgical fixation and stabilization of sacroiliac joint to promote fusion. Implanted by surgeons using specialized instrumentation. Device provides mechanical stabilization of joint; facilitates fusion process. MR conditional per ASTM standards.

Clinical Evidence

No clinical data provided. Bench testing only, specifically MR compatibility assessment per ASTM F2052-06, ASTM F2182-11A, and ASTM F2119-07.

Technological Characteristics

Metallic (titanium) rods with porous plasma spray coating. Dimensions: 30-90mm length, 4-7mm diameter. MR conditional per ASTM F2503-08. Mechanical fixation device.

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to sacroiliac joint disruptions or degenerative sacroiliitis.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• iFuse Implant System (K080398, K092375, K110838, K122074, K123850)
• Pioneer Cannulated Screw System (K102903)

Submission Summary (Full Text)

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# 510(k) SUMMARY

## iFuse Implant System®

# 510(k) Owner's Name, Address, and Telephone Number SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 [phone]

#### Contact Person

Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to SI-BONE, Inc. Email: [e-mail] Phone: [phone] Mobile: [phone] Facsimile: 650-343-7822

OCT 1 6 2013

Date Prepared: October 4, 2013

Trade Name of Device: iFuse Implant System®

Common or Usual Name: Orthopedic Rod

#### Classification Name:

21 C.F.R. 888,3040 - Smooth or threaded metallic bone fastener; Product Code OUR

#### Predicate Devices:

iFuse Implant System® by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850) Pioneer Cannulated Screw System by Pioneer Surgical Technology (K102903)

#### Intended Use

The iFuse System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

#### Device Description

The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838, K122074 and K123850.

#### Technological Characteristics

The iFuse Implant System® consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone to create fixation/stabilization and

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#### K131405 (pg 2/2)

fusion. There are no changes to the technological characteristics of the predicate device that are the subject of this 510(k).

# Performance Data

Magnetic resonance (MR) imaging testing was performed to assess the compatibility and safety under typical MR conditions following aspects of ASTM F2052-06, ASTM F2182-11A and ASTM F2119-07. The iFuse Implant is MR conditional and labeled in compliance with ASTM F2503-08.

#### Substantial Equivalence

The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, the iFuse Implant System is substantially equivalent to the predicate device.

Further, the proposed longer device length is substantially equivalent to the Pioneer Cannulated Screw System manufactured by Pioneer Surgical Technology (Class II, Product Codes HWC, OUR; 21 CFR 888.3040).

#### Conclusions

The iFuse Implant System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2013

SI-BONE, Incorporated % Ms. Cindy Domecus Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K131405

Trade/Device Name: SI-BONE iFuse Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: September 18, 2013 Received: September 19, 2013

Dear Ms. Domecus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Ms. Cindy Domecus

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Erin] ( Erin Erin

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K131405 (pg 1/1)

Device Name: SI-BONE iFuse Implant System

Indications for Use:

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

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Division of Orthopedic Devices